Inhibitor Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed May 14, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 14, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Condensed Financial Statements
1. Corporate Overview
Overview
The accompanying condensed financial statements of the Company have been prepared without audit. In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present fairly the financial position, results of operations and cash flows as of March 31, 2025, and for all periods presented, have been made.
Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2024, which are included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “2024 Annual Report”). The accompanying condensed balance sheet as of December 31, 2024 has been derived from the audited financial statements at that date but does not include all information and footnotes required by GAAP for complete financial statements.
As used herein, the term “common stock” means the Company’s common stock, $0.0001 par value per share.
The results of operations for the three-month period ended March 31, 2025, are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. Readers of this Quarterly Report are strongly encouraged to review the risk factors relating to the Company which are set forth in the 2024 Annual Report and the Company’s other filings with the SEC.
Nature of the Business
The Company is a pharmaceutical development company focused on developing and ultimately commercializing innovative therapeutics based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery for patients with certain cancers and certain non-cancerous proliferation disorders. The Company has also explored and expects to continue to explore acquiring or licensing other innovative pre-clinical and clinical stage therapeutics addressing unmet needs for the treatment of cancer and other diseases based on repurposing active ingredients of already approved drugs.
The Company’s primary focus is on the development of therapies initially for basal cell carcinoma (“BCC”), prostate and lung cancers in the United States utilizing itraconazole, a drug currently approved by the U.S Food and Drug Administration (“FDA”) to treat fungal infections, and which has an extensive history of safe and effective use in humans. The Company has developed intellectual property and know-how related to the treatment of cancer patients using itraconazole. In particular, on December 12, 2023, the Company entered into an Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”). Pursuant to the Agreement, JHU granted to the Company the exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled “New Angiogenesis Inhibitors” (the “Patent”). The Patent relates to the treatment of prostate cancer, BCC including basal cell carcinoma nevus syndrome (“BCCNS”), and lung cancer.
2. Liquidity and Management’s Plans
The Company is presently focused on its business plan for developing and ultimately commercializing innovative therapeutics based on already approved active pharmaceuticals that have patent-protected methods of use and/or methods of delivery. The Company expects to progress with the FDA in 2025 with a new formulation of itraconazole (the API: Active Pharmaceutical Ingredient) developed with Avior Bio, Inc. (“Avior”; see Note 4), coupled with a crossover PK trial to show that our formulation of itraconazole delivers comparable levels of itraconazole as the SUBA Cap formulation used in prior clinical trials. As such, we expect to justify the conclusion that we can submit an NDA without any required additional clinical trials. The current cash on hand, approximately $4.3 million on March 31, 2025, is sufficient to continue to execute the Company’s business plan as currently anticipated, without another required clinical trial. Based on the current operational plan and budget, the Company expects to have sufficient cash to manage its business and continue to pursue the FDA process for the BCCNS product (without further clinical trials) and explore other drug development opportunities. Once the requirements for the BCCNS NDA are determined, the Company will assess capital requirements for additional opportunities, at which time raising additional capital in the public market will be considered.
3. Summary of Significant Accounting Policies
Estimates
The preparation of condensed financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
Revenue Recognition
The Company currently has no ongoing source of revenue. Miscellaneous income, including interest, is recognized when earned by the Company. Deferred revenue represents cash received for royalties in advance of being earned. Such payments are reflected as deferred revenue until recognized under the Company’s revenue recognition policy. Deferred revenue would be classified as current if management believes the Company will be able to recognize the deferred amount as revenue within twelve months of the balance sheet date. Deferred revenue will be recognized when the product is sold and the royalty is earned. Since all deferred revenue is related to the BCCNS product, which is yet to be approved by FDA, the Company has determined that 100% of the advances of the royalty received from Mayne Pharma Ventures Pty Ltd. (“Mayne Pharma”) should be classified as non-current. As of March 31, 2025 and December 31, 2024, deferred revenue consisted of $3 million of royalties advanced by Mayne Pharma under the Third Amended Supply and License Agreement (“SLA”).
Cash and Cash Equivalents
The Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents. The Company maintains cash balances in bank accounts in excess of Federal Deposit Insurance Corporation insured amounts. The Company continues to monitor the third-party depository institutions that hold the Company’s cash and limits its cash deposits to financial institutions with high credit standing.
Research and Development Expenses
Research and development (“R&D”) costs are expensed in the period in which they are incurred and include salaries, benefits and other related costs to support the Company’s R&D operations, amounts paid to third parties who conduct research and development activities on behalf of the Company, as well as the costs of discovery research, preclinical and clinical development, drug formulation and licensing payments. Upfront and advanced licensing payments for future use in R&D activities are recorded as prepaid expenses and are expensed as the related services are performed.
General and Administrative Expenses
General and administrative (“G&A”) expenses are expensed in the period in which they are incurred and include operating expenses not classified as R&D expenses, such as salaries, benefits, insurance, board of directors’ fees, travel costs, as well as fees for professional services related to accounting, tax and legal matters.
Stock-Based Compensation
The Company accounts for stock-based awards to employees and non-employees using a fair value-based method to determine compensation for all arrangements where shares of stock or equity instruments are issued for compensation. Fair values of restricted stock units issued are determined by the Company based predominantly on the trading price of the common stock on the date of grant. The fair value of each common stock option is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatility is based on historical volatility of a peer group’s common stock and other factors estimated over the expected term of the options. The expected term of the options granted is derived using the “simplified method” which computes the expected term as the average of the weighted-average vesting term and the contract term. The risk-free rate is based on the U.S. Treasury yield.
Income Taxes
Deferred tax assets and liabilities are recognized for future tax consequences attributed to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and are measured using enacted tax rates that are expected to apply to the differences in the periods that they are expected to reverse.
Leases
The Company recognizes on its balance sheet right-of-use assets and lease liabilities associated with lease agreements based on the present value of the future lease payments over the contractual lease term using its incremental borrowing rate on the lease commencement date. The Company has elected not to recognize a lease liability or right-of-use asset on the balance sheet for leases with an initial term of 12 months or less. Operating lease expenses on capitalized leases and short-term leases are recognized on a straight-line basis over the respective lease term, inclusive of rent escalation provisions and rent abatements, as a component of general and administrative expenses in the statements of operations.
Reclassifications
Certain prior year amounts have been reclassified to conform to current year presentation. The reclassifications relate to certain expenses incurred by the Company that were reclassified from G&A expenses to R&D expenses to better align with the nature of the expenditures. The reclassifications had no impact on the Company’s previously reported financial position, results of operations or cash flows.
Recent accounting pronouncements
Management has considered all recent accounting pronouncements issued, but not effective, and does not believe that any will have a material impact on the Company’s results of operations or financial position.
4. Related Party Transactions
The Company has engaged Avior, which is currently creating a novel formulation of itraconazole from which results are expected in the third quarter of 2025. Avior is a privately held drug development company whose President and Chairman of the Board, Niraj Vasisht, is a member of the Company’s Board of Directors. Upon finalization of the formulation, Avior will conduct a pharmacokinetic (PK) crossover study to the generic formulation and the formulation that was used within the HP2001 study in preparation for a new IND and NDA. Given all formulations consist of the same active pharmaceutical ingredients (API), it is expected that the Company’s new, novel formulation will have extremely similar properties to the formulation used in the HP2001 clinical study. During the three months ended March 31, 2025 and 2024, the Company didnot incur any costs associated with its engagement of Avior.
5. Stockholders’ Equity
Employee Stock Plans
During the three months ended March 31, 2024, the Company granted 300,000 restricted shares of common stock with an aggregate grant date fair value of approximately $0.02 million to the members of the Board of Directors under the equity incentive plan. The shares of common stock were fully vested upon issuance but are restricted from trading for a period of one year from the date of grant. There wereno grants of restricted common stock during the three months ended March 31, 2025.
During the three months ended March 31, 2024, the Company issued 270,000 common stock options with an exercise price of $0.08 per share and a grant date fair value of $0.07 per share. The aggregate fair value of the options issued was approximately $0.02 million, as determined by using the Black-Scholes valuation model. The assumptions used to estimate the fair value of the options issued during the period were as follows: risk-free interest rate:4.33%; expected term: five years; expected volatility:129.8%; andno dividend yield. The options are fully vested upon issuance and the contractual terms expire in 2034. There wereno common stock options issued during the three months ended March 31, 2025.
As of March 31, 2025, there were 2,865,646 outstanding common stock options under the Company’s equity incentive plan of which 100% were vested. There was no unamortized stock-based compensation as of March 31, 2025. The weighted-average remaining contractual life, weighted-average exercise price per share and the aggregate intrinsic value of the outstanding common stock options as of March 31, 2025 were 5.0 years, $0.09 and approximately $0.01 million, respectively.
6. Commitments and Contingencies
Legal Proceedings
The Company may from time to time become a party to various legal proceedings arising in the ordinary course of business. The Company is not currently the subject of any pending legal proceedings.
7. Leases
During the three months ended March 31, 2025, the Company executed a lease agreement for office space utilized by finance and operations staff. The lease term is three years with a commencement date of March 1, 2025 with no renewal options available. Previously, the Company leased office space under a short-term lease agreement used for the same purpose, which expired on March 31, 2025.
The components of lease costs were as follows:
| Three months ended March 31, | |||
|---|---|---|---|
| 2025 · 2024 | |||
| Operating lease cost | $2,693 | $ | - |
| Short-term lease cost | 9,901 | 4,770 | |
Supplemental information relating to leases was as follows:
| Three months ended March 31, | |||
|---|---|---|---|
| 2025 · 2024 | |||
| Cash paid for amounts included in measurement of lease obligations: | |||
| Operating cash flows related to operating lease | $2,613 | $ | - |
Weighted average remaining lease terms and discount rates were as follows:
| As of March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Operating lease: | ||
| Remaining lease term | 2.9 years | - |
| Discount rate | 7.5% | - |
Future minimum lease payments under non-cancelable operating lease agreement as of March 31, 2025 were as follows:
| Remainder of 2025 | $23,517 |
| 2026 | 32,140 |
| 2027 | 33,104 |
| 2028 | 5,544 |
| Total undiscounted minimum lease payments | 94,305 |
| Less: imputed interest | (9,957) |
| Present value of lease obligations | $84,348 |
The Company has entered into an agreement with a third party to share the utilization of the leased office space and the related costs associated with the use of the space, which require the Company to be reimbursed by the third party for 50% of all rent payments due under the lease. Despite this arrangement, the Company has not been relieved of its primary obligations under the lease agreement and as a result, the contractual lease payments in the table above as well as the right-of-use asset and lease obligation balances recognized on the balance sheet do not reflect any reductions for the reimbursement of lease costs from the third party.
FOR THE THREE MONTHS ENDED MARCH 31, 2025, AND 2024
8. Segment Information
The Company operates in one reportable segment related to the development and commercialization of therapeutics. The chief operating decision maker for the Company is the Chief Executive Officer (the “CEO”). The Company’s CEO reviews operating results on an aggregate basis and manages the Company’s operations as a whole for the purpose of evaluating financial performance and allocating resources. Accordingly, the Company has determined that it has a single reportable and operating segment structure. The CEO uses aggregate net loss to allocate resources in the annual budgeting and forecasting process and also uses that measure as a basis for evaluating financial performance regularly by comparing actual results with established budgets and forecasts.
The accounting policies of the Company’s single segment are the same as those described in the summary of significant accounting policies within Note 3. The CEO assesses performance for the Company and decides how to allocate resources based on the aggregate net loss that is also reported on the income statement as net loss. The measure of segment assets is reported on the balance sheets as total assets.
The table below provides information about the Company’s revenue, significant segment expenses and other segment expenses.
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Revenues | $— | $— |
| Less: | ||
| Research and development | 236,058 | 260,359 |
| General and administrative | 438,493 | 514,458 |
| Loss from operations | (674,551) | (774,817) |
| Plus: | ||
| Interest income | 41,705 | 90,106 |
| Net loss | $(632,846) | $(684,711) |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.